(68 days)
The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm). The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.
The provided 510(k) summary for the Lutronic Corporation MOSAIC Laser System (K080932) indicates that the device's performance was established through a comparison to a predicate device rather than through specific acceptance criteria and a standalone human factors study or a multi-reader, multi-case study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "similar histological effects as the predicate device" |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the sense of a clinical trial with a defined sample size. The "performance data" mentioned refers to histological effects, likely from pre-clinical testing or animal studies, but the specific sample size, data provenance (country of origin), or whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the "similar histological effects" would typically be established by a pathologist reviewing tissue samples. However, no details on the number or qualifications of such experts are provided in this document.
4. Adjudication method for the test set
Not applicable. No information is provided regarding an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a laser system, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a "standalone" study in the context of an algorithm's performance was not done. The device is a physical laser system, and its performance is evaluated based on its physical and biological effects.
7. The type of ground truth used
The type of ground truth used was histology for assessing "similar histological effects."
8. The sample size for the training set
Not applicable. This device is a laser system, not a machine learning algorithm. Therefore, there is no "training set" in the context of artificial intelligence.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.